This short report provides details of the regulatory requirements and operational considerations when conducting non-interventional studies (NIS) in Mexico.
- Title: NIS Considerations – Mexico (2015)
- Publication Date: 24 November 2015
- No. of Pages: 2o
- Format: PDF
- Author/ Editor: Stuart McCully
Table of Contents:
- DISCLAIMER
- REGULATORY BODIES
- SUMMARY OF THE COUNTRY-SPECIFIC REGULATORY REQUIREMENTS
- REGULATORY SUBMISSIONS DOCUMENTS
- Regulatory Submissions Document Checklist
- Which Documents Need to Be Translated?
- Who is Responsible for What?
- STUDY CONDUCT CONSIDERATIONS
- APPLICABLE LEGISLATION AND GUIDELINES
- USEFUL LINKS
- Regulatory Requirements
- Data Privacy Considerations
- Study Conduct Considerations
- Best Practice Considerations
- ANNEX 1: TEMPLATE COVER LETTER